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Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation — IXO-01  

Lyme Disease Clinical Trial

Official title:
A Single Centre, Randomized, Investigator Blinded, Placebo-controlled Ascending Dose Study to Assess the Local Safety, the Skin and Plasma Concentration of Azithromycin Dermal Formulation During Repeated Applications on the Skin of Healthy Volunteers

Clinical Trial Summary

IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.

Clinical Trial Description

In this study two consecutive cohorts will be treated:

- Cohort 1: 8 volunteers

- Cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each

The study will be conducted in the following three phases:

1. Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a local treatment with azithromycin dermal formulation.

1. Treatment of cohort 1 with azithromycin dermal formulation and follow up

2. Assessment of local safety within the 7 days following the first treatment

3. The maximal tolerated dose (MTD) will be determined

2. Treatment of cohort 2: The aim is to confirm the local tolerance of the selected doses and to evaluate the local skin and plasma concentration of azithromycin after application of SHB001 dermal formulation.

1. Treatment of cohort 2 with azithromycin dermal formulation at maximal tolerated dose (MTD), with a dose one or more concentrations lower than maximal tolerated dose (MTD) and with placebo

2. Skin biopsies of treated skin areas will be taken for the PK assessment

3. Study completion examination ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01243008
Study type Interventional
Source University of Zurich
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 2010
Completion date November 2010
View Details
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